FDA 510(k) Application Details - K012520

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K012520
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	CARDIAC ASSIST DEVICES, INC. 11000 CEDAR AVE., SUITE 451 CLEVELAND, OH 44106-3052 US Other 510(k) Applications for this Company
Contact	RASSOLL RASHIDI Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2001
Decision Date	03/27/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review